Multi-Dose Medical Fluid Injection System Having Patient-Specific Tubing Set with Use Indicator

ABSTRACT

A single-use, single-patient, or patient-specific tubing set ( 300 ) is disclosed. The tubing set ( 300 ) includes at least one check valve ( 304 ), along with a use indicator ( 320 ). This use indicator ( 320 ) provides a visual indication when the tubing set ( 300 ) has been used for an injection. In this regard, a piston ( 340 ) moves from one position to another when exposed to a certain fluid pressure.

RELATED APPLICATIONS

This application is a divisional patent application of U.S. patentapplication Ser. No. 13/144,304, filed 13 Jul. 2011, which is a U.S.National Stage of PCT/US2010/029895, filed 5 Apr. 2010, which claimspriority to and is a non-provisional application of U.S. ProvisionalApplication Ser. No. 61/167,551 filed on 8 Apr. 2009 entitled“MULTI-DOSE MEDICAL FLUID INJECTION SYSTEM HAVING PATIENT-SPECIFICTUBING SET WITH USE INDICATOR”. Priority is claimed to each patentapplication set forth in this Related applications section, and thesubject matter of each such application is incorporated by reference inits entirety.

FIELD OF THE INVENTION

The present invention generally relates to the field of medical fluidinjection systems having a reusable or multi-patient tubing set (e.g.,for use with multiple patients), along with a disposable or single-useor patient-specific tubing set (e.g., for use with a single patient).

BACKGROUND

Various medical procedures require that one or more medical fluids beinjected into a patient. For example, medical imaging proceduresoftentimes involve the injection of contrast media into a patient,possibly along with saline or other fluids. Other medical proceduresinvolve injecting one or more fluids into a patient for therapeuticpurposes. Power injectors may be used for these types of applications.

A power injector generally includes what is commonly referred to as apowerhead. One or more syringes may be mounted to the powerhead invarious manners (e.g., detachably; rear-loading; front-loading;side-loading). Each syringe typically includes what may be characterizedas a syringe plunger, piston, or the like. Each such syringe plunger isdesigned to interface with (e.g., contact and/or temporarilyinterconnect with) an appropriate syringe plunger driver that isincorporated into the powerhead, such that operation of the syringeplunger driver axially advances the associated syringe plunger insideand relative to a barrel of the syringe. One typical syringe plungerdriver is in the form of a ram that is mounted on a threaded lead ordrive screw. Rotation of the drive screw in one rotational directionadvances the associated ram in one axial direction, while rotation ofthe drive screw in the opposite rotational direction advances theassociated ram in the opposite axial direction.

One way to categorize syringes used by power injectors is the manner inwhich they are filled or loaded with fluid. Power injector syringes maybe pre-filled—syringes that are filled with fluid at one facility andthen shipped to another facility (e.g., an end-use facility). Emptysyringes may be shipped to the end-use facility, and may then be filledwith fluid in at least two general manners. An empty syringe may befilled with fluid at one location within the end-use facility (e.g., ata filling station), and then transferred to another location within theend-use facility (e.g., an imaging suite) where the fluid-containingsyringe is then installed on a power injector. Alternatively, an emptysyringe may be installed on a power injector at the end-use facility(e.g., in an imaging suite) and then loaded or filled with fluid.

Individual empty syringes may be filled in accordance with the foregoingfrom what may be characterized as a single dose container. In this case,the syringe is used for a single injection on a single patient. Anycontrast media remaining in the syringe after this single injection isthereby wasted. The entire tubing set extending from the power injectorto the patient (including the various components that may beincorporated into the tubing set, such as one or more valves and acatheter) is also discarded.

SUMMARY

As used herein, the phrase “fluidly interconnected” or the like refersto two or more components or entities being connected (directly orindirectly) in a manner such that fluid can flow (e.g., unidirectionallyor bidirectionally) between the components or entities. For example, “aninjection device being fluidly interconnected to a patient” describes aconfiguration where fluid can flow from the injection device, throughany interconnecting device(s) (e.g., tubing, connectors), and to thepatient (e.g., into the vasculature of the patient).

As used herein, the phrase “fluidly isolated” or the like describes arelationship between components or entities where it is intended thatfluid be at least temporarily precluded from flowing between thecomponents or entities. For example, “an injection device being fluidlyisolated from a patient” describes a configuration where fluid from theinjection device is intended to be at least temporarily precluded fromflowing to the patient. Such an inability to flow may be because nointerconnecting device(s) currently fluidly interconnects the injectiondevice and the patient or because one or more devices, such as a valve,is currently in a configuration or position that is intended to precludeflow between the injection device and the patient.

As used herein, the phrase “detachably interconnected” describes arelationship between components or entities where the components orentities are interconnected yet retain the ability to be detached ordisconnected from each other where, after being detached ordisconnected, at least one of the components or entities remains incondition for re-use. For example, “a multi-patient tubing set beingdetachably interconnected with a patient-specific tubing set” describesa condition where the multi-patient tubing set is currentlyinterconnected with the patient-specific tubing in a manner that allowsfor the multi-patient tubing set to be detached or disconnected from thepatient-specific tubing set. Furthermore, after being disconnected, atleast one of the multi-patient tubing set and the patient-specifictubing set retains the ability to be interconnected (e.g., detachably)with another component (e.g., such that the same multi-patient tubingset may be interconnected at one time with one patient-specific tubingset, and after being disconnected therefrom, may be interconnected withanother patient-specific tubing set).

A first aspect of the present invention is embodied by a medical fluidinjection system that uses an injection device, a multi-patient tubingset, and a patient-specific tubing set. The multi-patient tubing set isdisposed between the patient-specific tubing set and the injectiondevice (e.g., by a detachable interconnection between the multi-patienttubing set and the patient-specific tubing set). The patient-specifictubing set includes at least one valve, along with a use indicator thatis movable from a first position to a second position in response to aflow through the patient-specific tubing set.

A second aspect of the present invention is embodied by a medical fluidinjection system that uses an injection device, a multi-patient tubingset, and a patient-specific tubing set. The multi-patient tubing set isdisposed between the patient-specific tubing set and the injectiondevice (e.g., by a detachable interconnection between the multi-patienttubing set and the patient-specific tubing set). The patient-specifictubing set includes at least one valve, along with a use indicator. Theuse indicator includes a housing and a piston that is movably disposedwithin the housing, where the piston interfaces with a flowpath throughthe housing.

A number of feature refinements and additional features are separatelyapplicable to each of the first and second aspects of the presentinvention. These feature refinements and additional features may be usedindividually or in any combination. As such, each of the followingfeatures that will be discussed may be, but are not required to be, usedwith any other feature or combination of features of the first andsecond aspects. The following discussion is separately applicable toeach of the first and second aspects, up to the start of the discussionof a third aspect of the present invention.

Any appropriate valve may be utilized by the patient-specific tubingset, for instance a check valve. First and second valves (e.g., dualcheck valves) may be disposed along a flowpath through thepatient-specific tubing set. One or more valves may be utilized by thepatient-specific tubing set to reduce the potential that contaminants ofany type will be able to proceed beyond such valves and reach themulti-patient tubing set and/or the injection device. Contamination ofthe multi-patient tubing set and/or the injection device could affectthe ability of the same to be used for subsequent injections withoutfirst sterilizing the same (e.g., for different patients).

Having the use indicator in its second position may be for purposes ofproviding a visual indication that the patient-specific tubing set hasbeen used (e.g., such that it should be discarded; such that it shouldnot be re-used without first being sterilized). The use indicator may belocked after being moved into its second position. The use indicator maybe in a protruded configuration in its second position, and as such theuse indicator may be characterized as a pop-up or pop-out indicator.

The use indicator may include a housing and a piston that is movablydisposed within the housing, where the piston interfaces with a flowpaththrough the housing. As such, fluid within the flowpath may contact thepiston, and the pressure of the fluid within the flowpath may exert aforce on the piston. The piston may move axially from a first positionto a second position, may move along a path that is orthogonal to a flowthrough the housing, or both when the piston is exposed to a certainfluid pressure within the flowpath through the housing. At least part ofthe piston may protrude or extend beyond the housing when the piston isin its second position. The piston may be characterized as beingdirected into an open space when moving from its first position to itssecond position (e.g., such that the piston interfaces with this openspace—or such that the piston does not come into physical contact withanother structure (a structure in addition to the use indicator) bymoving from its first position to its second position). One or moredetents or the like may be incorporated into the housing to lock orrestrain the piston after having moved to its second position. In oneembodiment, a fluid pressure of at least 15 psi is required to move thepiston from its first position to its second position.

The injection device may be of any appropriate type, for instance apower injector. The system may include other components. In oneembodiment, the system includes a fluid source that may be used to“re-load” the injection device (e.g., for providing an injection toanother patient, after switching out the prior patient-specific tubingset for a new patient-specific tubing set).

A third aspect of the present invention is embodied by a method of usinga medical fluid injection system. A first patient-specific tubing set isinterconnected with a multi-patient tubing set. Fluid is directedthrough the multi-patient tubing set, and then through the firstpatient-specific tubing set. Any backflow through the firstpatient-specific tubing set is exposed to a blocking action, and therebyis not intended to be able to reach the multi-patient tubing set (e.g.,such that the multi-patient tubing set should not become contaminated sothat it may be re-used on a different patient). The firstpatient-specific tubing set may include a first use indicator, and asingle response in the form of a physical change is induced when thefirst use indicator is exposed to at least a certain condition.

A number of feature refinements and additional features are applicableto the third aspect of the present invention. These feature refinementsand additional features may be used individually or in any combination.As such, each of the following features that will be discussed may be,but are not required to be, used with any other feature or combinationof features of the third aspect. The following discussion is applicableat least to the third aspect of the present invention.

The “physical change” of the first use indicator may be of anyappropriate type. Representative physical changes may be a change insize of the overall first use indicator, a change in shape of theoverall first use indicator, or both. For instance and for the casewhere the first use indicator is in the form of a piston movablydisposed relative to a housing, the physical change may result from amovement of the piston relative to the housing (e.g., to a protruding or“more protruding” position relative to the housing). Even though thepiston may not deform to provide this movement, the overall shape of thefirst use indicator may still be properly characterized as havingchanged when the piston moves to a protruding/more protruded positionrelative to the housing.

The single induced response of the first use indicator may be a movementof a first indicator element from a first position to a second position.The first indicator element may be retained after having been moved intoits second position. The movement of the first indicator element issubject to a number of characterizations. One is that this movement maybe initiated without any deformation of the first indicator element—thefirst indicator element itself need not experience a change in sizeand/or shape in moving from the first position to the second position inthis characterization. Another is that this movement may entail movingthe first indicator element into a visibly observable position (e.g., aprotruding position). Yet another is that this movement may entailmoving the first indicator element into an open space. In oneembodiment, the first indicator element is in the form of a piston.

The first patient-specific tubing set may be disconnected from themulti-patient tubing set (e.g., after completion of an injectionprotocol in relation to a first patient, where fluid is injected intothe first patient), and a second patient-specific tubing set may beconnected with the multi-patient tubing set. The various stepsassociated with the first patient-specific tubing set may be repeatedfor this second patient-specific tubing set (e.g., an injection protocolmay be executed in relation to a second patient, where fluid is injectedinto the second patient). The fluid directed through each of the firstand second patient-specific tubing sets may be acquired from a commonfluid source.

A number of feature refinements and additional features are separatelyapplicable to each of above-noted first, second, and third aspects ofthe present invention. These feature refinements and additional featuresmay be used individually or in any combination in relation to each ofthe above-noted first, second, and third aspects of the presentinvention. Any feature of any other various aspects of the presentinvention that is intended to be limited to a “singular” context or thelike will be clearly set forth herein by terms such as “only,” “single,”“limited to,” or the like. Merely introducing a feature in accordancewith commonly accepted antecedent basis practice does not limit thecorresponding feature to the singular (e.g., indicating that a powerinjector includes “a syringe” alone does not mean that the powerinjector includes only a single syringe). Moreover, any failure to usephrases such as “at least one” also does not limit the correspondingfeature to the singular (e.g., indicating that a power injector includes“a syringe” alone does not mean that the power injector includes only asingle syringe). Use of the phrase “at least generally” or the like inrelation to a particular feature encompasses the correspondingcharacteristic and insubstantial variations thereof (e.g., indicatingthat a syringe barrel is at least generally cylindrical encompasses thesyringe barrel being cylindrical). Finally, use of the phrase “in oneembodiment” in relation to one or more features does not limit the useof the associated feature(s) to a single embodiment.

An injection device may be used to deliver fluid using the multi-usefluid set and at least one patient-specific fluid set. In oneembodiment, the injection device is a power injector. Any power injectorthat may be utilized to provide a fluid discharge may be of anyappropriate size, shape, configuration, and/or type. Any such powerinjector may utilize one or more syringe plunger drivers of anyappropriate size, shape, configuration, and/or type, where each suchsyringe plunger driver is capable of at least bi-directional movement(e.g., a movement in a first direction for discharging fluid; a movementin a second direction for accommodating a loading of fluid or so as toreturn to a position for a subsequent fluid discharge operation), andwhere each such syringe plunger driver may interact with itscorresponding syringe plunger in any appropriate manner (e.g., bymechanical contact; by an appropriate coupling (mechanical orotherwise)) so as to be able to advance the syringe plunger in at leastone direction (e.g., to discharge fluid). Each syringe plunger drivermay utilize one or more drive sources of any appropriate size, shape,configuration, and/or type. Multiple drive source outputs may becombined in any appropriate manner to advance a single syringe plungerat a given time. One or more drive sources may be dedicated to a singlesyringe plunger driver, one or more drive sources may be associated withmultiple syringe plunger drivers (e.g., incorporating a transmission ofsorts to change the output from one syringe plunger to another syringeplunger), or a combination thereof. Representative drive source formsinclude a brushed or brushless electric motor, a hydraulic motor, apneumatic motor, a piezoelectric motor, or a stepper motor.

Any such power injector may be used for any appropriate applicationwhere the delivery of one or more medical fluids is desired, includingwithout limitation any appropriate medical application (e.g., computedtomography or CT imaging; magnetic resonance imaging or MRI; singlephoton emission computed tomography or SPECT imaging; positron emissiontomography or PET imaging; X-ray imaging; angiographic imaging; opticalimaging; ultrasound imaging). Any such power injector may be used inconjunction with any component or combination of components, such as anappropriate imaging system (e.g., a CT scanner). For instance,information could be conveyed between any such power injector and one ormore other components (e.g., scan delay information, injection startsignal, injection rate).

Any appropriate number of syringes may be utilized with any such powerinjector in any appropriate manner (e.g., detachably; front-loaded;rear-loaded; side-loaded), any appropriate medical fluid may bedischarged from a given syringe of any such power injector (e.g.,contrast media, a radiopharmaceutical, saline, and any combinationthereof), and any appropriate fluid may be discharged from a multiplesyringe power injector configuration in any appropriate manner (e.g.,sequentially, simultaneously), or any combination thereof. In oneembodiment, fluid discharged from a syringe by operation of the powerinjector is directed into a conduit (e.g., medical tubing set), wherethis conduit is fluidly interconnected with the syringe in anyappropriate manner and directs fluid to a desired location (e.g., to acatheter that is inserted into a patient, for instance for injection).Multiple syringes may discharge into a common conduit (e.g., forprovision to a single injection site), or one syringe may discharge intoone conduit (e.g., for provision to one injection site), while anothersyringe may discharge into a different conduit (e.g., for provision to adifferent injection site). In one embodiment, each syringe includes asyringe barrel and a plunger that is disposed within and movablerelative to the syringe barrel. This plunger may interface with thepower injector's syringe plunger drive assembly such that the syringeplunger drive assembly is able to advance the plunger in at least onedirection, and possibly in two different, opposite directions.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic of one embodiment of a power injector.

FIG. 2A is a perspective view of one embodiment of a portablestand-mounted, dual-head power injector.

FIG. 2B is an enlarged, partially exploded, perspective view of apowerhead used by the power injector of FIG. 2A.

FIG. 2C is a schematic of one embodiment of a syringe plunger driveassembly used by the power injector of FIG. 2A.

FIG. 3A is a perspective view of one embodiment of a multi-doseinjection system.

FIG. 3B is a perspective view of a bulk fluid container holder modulethat may be used by the multi-dose injection system of FIG. 3A.

FIG. 4A is a perspective view of a multi-use tubing set that may be usedby the multi-dose injection system of FIG. 3A.

FIG. 4B is a perspective view of a patient-specific tubing set that maybe used by the multi-dose injection system of FIG. 3A.

FIG. 5A is a perspective top view of a cassette used by the multi-doseinjection system of FIG. 3A.

FIG. 5B is a perspective bottom view of the cassette of FIG. 5A.

FIG. 6 is a flowchart of a method of delivering medical fluid to aplurality of patients from the multi-dose injection system.

FIG. 7 is a schematic of another embodiment of a multi-dose injectionsystem that uses both a multi-patient tubing set and a patient-specifictubing set.

FIG. 8 is a schematic of another embodiment of a multi-dose injectionsystem that uses both a multi-patient tubing set and a patient-specifictubing set.

FIG. 9A is a perspective view of one embodiment of a patient-specifictubing set that may be used by the multi-dose injection systems of FIGS.7-8.

FIG. 9B is a perspective view of the indicator from the patient-specifictubing set of FIG. 9A and in its “used” position.

FIG. 9C is a cross-sectional view of the indicator from thepatient-specific tubing set of FIG. 9A.

DETAILED DESCRIPTION

FIG. 1 presents a schematic of one embodiment of an injection device inthe form of a power injector 10 having a powerhead 12. One or moregraphical user interfaces or GUIs 11 may be associated with thepowerhead 12. Each GUI 11: 1) may be of any appropriate size, shape,configuration, and/or type; 2) may be operatively interconnected withthe powerhead 12 in any appropriate manner; 3) may be disposed at anyappropriate location; 4) may be configured to provide one or anycombination of the following functions: controlling one or more aspectsof the operation of the power injector 10; inputting/editing one or moreparameters associated with the operation of the power injector 10; anddisplaying appropriate information (e.g., associated with the operationof the power injector 10); or 5) any combination of the foregoing. Anyappropriate number of GUIs 11 may be utilized. In one embodiment, thepower injector 10 includes a GUI 11 that is incorporated by a consolethat is separate from but which communicates with the powerhead 12. Inanother embodiment, the power injector 10 includes a GUI 11 that is partof the powerhead 12. In yet another embodiment, the power injector 10utilizes one GUI 11 on a separate console that communicates with thepowerhead 12, and also utilizes another GUI 11 that is on the powerhead12. Each GUI 11 could provide the same functionality or set offunctionalities, or the GUIs 11 may differ in at least some respect inrelation to their respective functionalities.

A syringe 28 may be installed on the powerhead 12 and, when installed,may be considered to be part of the power injector 10. Some injectionprocedures may result in a relatively high pressure being generatedwithin the syringe 28. In this regard, it may be desirable to disposethe syringe 28 within a pressure jacket 26. The pressure jacket 26 istypically associated with the powerhead 12 in a manner that allows thesyringe 28 to be disposed therein as a part of or after installing thesyringe 28 on the powerhead 12. The same pressure jacket 26 willtypically remain associated with the powerhead 12, as various syringes28 are positioned within and removed from the pressure jacket 26 formultiple injection procedures. The power injector 10 may eliminate thepressure jacket 26 if the power injector 10 is configured/utilized forlow-pressure injections and/or if the syringe(s) 28 to be utilized withthe power injector 10 is (are) of sufficient durability to withstandhigh-pressure injections without the additional support provided by apressure jacket 26. In any case, fluid discharged from the syringe 28may be directed into a conduit 38 of any appropriate size, shape,configuration, and/or type, which may be fluidly interconnected with thesyringe 28 in any appropriate manner, and which may direct fluid to anyappropriate location (e.g., to a patient).

The powerhead 12 includes a syringe plunger drive assembly or syringeplunger driver 14 that interacts (e.g., interfaces) with the syringe 28(e.g., a plunger 32 thereof) to discharge fluid from the syringe 28.This syringe plunger drive assembly 14 includes a drive source 16 (e.g.,a motor of any appropriate size, shape, configuration, and/or type,optional gearing, and the like) that powers a drive output 18 (e.g., arotatable drive screw). A ram 20 may be advanced along an appropriatepath (e.g., axial) by the drive output 18. The ram 20 may include acoupler 22 for interacting or interfacing with a corresponding portionof the syringe 28 in a manner that will be discussed below.

The syringe 28 includes the plunger or piston 32 that is movablydisposed within a syringe barrel 30 (e.g., for axial reciprocation alongan axis coinciding with the double-headed arrow B). The plunger 32 mayinclude a coupler 34. This syringe plunger coupler 34 may interact orinterface with the ram coupler 22 to allow the syringe plunger driveassembly 14 to retract the syringe plunger 32 within the syringe barrel30. The syringe plunger coupler 34 may be in the form of a shaft 36 athat extends from a body of the syringe plunger 32, together with a heador button 36 b. However, the syringe plunger coupler 34 may be of anyappropriate size, shape, configuration, and/or type.

Generally, the syringe plunger drive assembly 14 of the power injector10 may interact with the syringe plunger 32 of the syringe 28 in anyappropriate manner (e.g., by mechanical contact; by an appropriatecoupling (mechanical or otherwise)) so as to be able to move or advancethe syringe plunger 32 (relative to the syringe barrel 30) in at leastone direction (e.g., to discharge fluid from the corresponding syringe28). That is, although the syringe plunger drive assembly 14 may becapable of bi-directional motion (e.g., via operation of the same drivesource 16), the power injector 10 may be configured such that theoperation of the syringe plunger drive assembly 14 actually only moveseach syringe plunger 32 being used by the power injector 10 in only onedirection. However, the syringe plunger drive assembly 14 may beconfigured to interact with each syringe plunger 32 being used by thepower injector 10 so as to be able to move each such syringe plunger 32in each of two different directions (e.g., in different directions alonga common axial path).

Retraction of the syringe plunger 32 may be utilized to accommodate aloading of fluid into the syringe barrel 30 for a subsequent injectionor discharge, may be utilized to actually draw fluid into the syringebarrel 30 for a subsequent injection or discharge, or for any otherappropriate purpose. Certain configurations may not require that thesyringe plunger drive assembly 14 be able to retract the syringe plunger32, in which case the ram coupler 22 and syringe plunger coupler 34 maynot be desired. In this case, the syringe plunger drive assembly 14 maybe retracted for purposes of executing another fluid delivery operation(e.g., after another pre-filled syringe 28 has been installed). Evenwhen a ram coupler 22 and syringe plunger coupler 34 are utilized, thesecomponents may or may not be coupled when the ram 20 advances thesyringe plunger 32 to discharge fluid from the syringe 28 (e.g., the ram20 may simply “push on” the syringe plunger coupler 34 or on a proximalend of the syringe plunger 32). Any single motion or combination ofmotions in any appropriate dimension or combination of dimensions may beutilized to dispose the ram coupler 22 and syringe plunger coupler 34 ina coupled state or condition, to dispose the ram coupler 22 and syringeplunger coupler 34 in an un-coupled state or condition, or both.

The syringe 28 may be installed on the powerhead 12 in any appropriatemanner. For instance, the syringe 28 could be configured to be installeddirectly on the powerhead 12. In the illustrated embodiment, a housing24 is appropriately mounted on the powerhead 12 to provide an interfacebetween the syringe 28 and the powerhead 12. This housing 24 may be inthe form of an adapter to which one or more configurations of syringes28 may be installed, and where at least one configuration for a syringe28 could be installed directly on the powerhead 12 without using anysuch adapter. The housing 24 may also be in the form of a faceplate towhich one or more configurations of syringes 28 may be installed. Inthis case, it may be such that a faceplate is required to install asyringe 28 on the powerhead 12—the syringe 28 could not be installed onthe powerhead 12 without the faceplate. When a pressure jacket 26 isbeing used, it may be installed on the powerhead 12 in the variousmanners discussed herein in relation to the syringe 28, and the syringe28 will then thereafter be installed in the pressure jacket 26.

The housing 24 may be mounted on and remain in a fixed position relativeto the powerhead 12 when installing a syringe 28. Another option is tomovably interconnect the housing 24 and the powerhead 12 to accommodateinstalling a syringe 28. For instance, the housing 24 may move within aplane that contains the double-headed arrow A to provide one or more ofcoupled state or condition and an un-coupled state or condition betweenthe ram coupler 22 and the syringe plunger coupler 34.

One particular power injector configuration is illustrated in FIG. 2A,is identified by a reference numeral 40, and is at least generally inaccordance with the power injector 10 of FIG. 1. The power injector 40includes a powerhead 50 that is mounted on a portable stand 48. A pairof syringes 86 a, 86 b for the power injector 40 are mounted on thepowerhead 50. Fluid may be drawn into and/or discharged from thesyringes 86 a, 86 b during operation of the power injector 40.

The portable stand 48 may be of any appropriate size, shape,configuration, and/or type. Wheels, rollers, casters, or the like may beutilized to make the stand 48 portable. The powerhead 50 could bemaintained in a fixed position relative to the portable stand 48.However, it may be desirable to allow the position of the powerhead 50to be adjustable relative to the portable stand 48 in at least somemanner. For instance, it may be desirable to have the powerhead 50 inone position relative to the portable stand 48 when loading or drawingfluid into one or more of the syringes 86 a, 86 b, and to have thepowerhead 50 in a different position relative to the portable stand 48for performance of an injection procedure. In this regard, the powerhead50 may be movably interconnected with the portable stand 48 in anyappropriate manner (e.g., such that the powerhead 50 may be pivotedthrough at least a certain range of motion, and thereafter maintained inthe desired position).

It should be appreciated that the powerhead 50 could be supported in anyappropriate manner for providing fluid. For instance, instead of beingmounted on a portable structure, the powerhead 50 could beinterconnected with a support assembly, that in turn is mounted to anappropriate structure (e.g., ceiling, wall, floor). Any support assemblyfor the powerhead 50 may be positionally adjustable in at least somerespect (e.g., by having one or more support sections that may berepositioned relative to one or more other support sections), or may bemaintained in a fixed position. Moreover, the powerhead 50 may beintegrated with any such support assembly so as to either be maintainedin a fixed position or so as to be adjustable relative the supportassembly.

The powerhead 50 includes a graphical user interface or GUI 52. This GUI52 may be configured to provide one or any combination of the followingfunctions: controlling one or more aspects of the operation of the powerinjector 40; inputting/editing one or more parameters associated withthe operation of the power injector 40; and displaying appropriateinformation (e.g., associated with the operation of the power injector40). The power injector 40 may also include a console 42 and powerpack46 that each may be in communication with the powerhead 50 in anyappropriate manner (e.g., via one or more cables), that may be placed ona table or mounted on an electronics rack in an examination room or atany other appropriate location, or both. The powerpack 46 may includeone or more of the following and in any appropriate combination: a powersupply for the injector 40; interface circuitry for providingcommunication between the console 42 and powerhead 50; circuitry forpermitting connection of the power injector 40 to remote units such asremote consoles, remote hand or foot control switches, or other originalequipment manufacturer (OEM) remote control connections (e.g., to allowfor the operation of power injector 40 to be synchronized with the x-rayexposure of an imaging system); and any other appropriate componentry.The console 42 may include a touch screen display 44, which in turn mayprovide one or more of the following functions and in any appropriatecombination: allowing an operator to remotely control one or moreaspects of the operation of the power injector 40; allowing an operatorto enter/edit one or more parameters associated with the operation ofthe power injector 40; allowing an operator to specify and storeprograms for automated operation of the power injector 40 (which canlater be automatically executed by the power injector 40 upon initiationby the operator); and displaying any appropriate information relation tothe power injector 40 and including any aspect of its operation.

Various details regarding the integration of the syringes 86 a, 86 bwith the powerhead 50 are presented in FIG. 2B. Each of the syringes 86a, 86 b includes the same general components. The syringe 86 a includesplunger or piston 90 a that is movably disposed within a syringe barrel88 a. Movement of the plunger 90 a along an axis 100 a (FIG. 2A) viaoperation of the powerhead 50 will discharge fluid from within thesyringe barrel 88 a through a nozzle 89 a of the syringe 86 a. Anappropriate conduit (not shown) will typically be fluidly interconnectedwith the nozzle 89 a in any appropriate manner to direct fluid to adesired location (e.g., a patient). Similarly, the syringe 86 b includesplunger or piston 90 b that is movably disposed within a syringe barrel88 b. Movement of the plunger 90 b in a first direction along an axis100 b (FIG. 2A) via operation of the powerhead 50 will discharge fluidfrom within the syringe barrel 88 b through a nozzle 89 b of the syringe86 b. Movement of the plunger 90 b in a direction opposite from thefirst direction along axis 100 b (FIG. 2A) via operation of thepowerhead 50 may, where the powerhead 50 is fluidly interconnected to asource of fluid, load fluid into the syringe barrel 88 b through thenozzle 89 b of the syringe 86 b. An appropriate conduit (not shown) willtypically be fluidly interconnected with the nozzle 89 b in anyappropriate manner to direct fluid to a desired location (e.g., apatient) and/or load fluid from a desired location (e.g., a fluidcontainer).

The syringe 86 a is interconnected with the powerhead 50 via anintermediate faceplate 102 a. This faceplate 102 a includes a cradle 104that supports at least part of the syringe barrel 88 a, and which mayprovide/accommodate any additional functionality or combination offunctionalities. A mounting 82 a is disposed on and is fixed relative tothe powerhead 50 for interfacing with the faceplate 102 a. A ram coupler76 of a ram 74 (FIG. 2C), which are each part of a syringe plunger driveassembly or syringe plunger driver 56 (FIG. 2C) for the syringe 86 a, ispositioned in proximity to the faceplate 102 a when mounted on thepowerhead 50. Details regarding the syringe plunger drive assembly 56will be discussed in more detail below in relation to FIG. 2C.Generally, the ram coupler 76 may be coupled with the syringe plunger 90a of the syringe 86 a, and the ram coupler 76 and ram 74 (FIG. 2C) maythen be moved relative to the powerhead 50 to move the syringe plunger90 a along the axis 100 a (FIG. 2A). It may be such that the ram coupler76 is engaged with, but not actually coupled to, the syringe plunger 90a when moving the syringe plunger 90 a to discharge fluid through thenozzle 89 a of the syringe 86 a.

The faceplate 102 a may be moved at least generally within a plane thatis orthogonal to the axes 100 a, 100 b (associated with movement of thesyringe plungers 90 a, 90 b, respectively, and illustrated in FIG. 2A),both to mount the faceplate 102 a on and remove the faceplate 102 a fromits mounting 82 a on the powerhead 50. The faceplate 102 a may be usedto couple the syringe plunger 90 a with its corresponding ram coupler 76on the powerhead 50. In this regard, the faceplate 102 a includes a pairof handles 106 a. Generally and with the syringe 86 a being initiallypositioned within the faceplate 102 a, the handles 106 a may be moved toin turn move/translate the syringe 86 a at least generally within aplane that is orthogonal to the axes 100 a, 100 b (associated withmovement of the syringe plungers 90 a, 90 b, respectively, andillustrated in FIG. 2A). Moving the handles 106 a to one positionmoves/translates the syringe 86 a (relative to the faceplate 102 a) inan at least generally downward direction to couple its syringe plunger90 a with its corresponding ram coupler 76. Moving the handles 106 a toanother position moves/translates the syringe 86 a (relative to thefaceplate 102 a) in an at least generally upward direction to uncoupleits syringe plunger 90 a from its corresponding ram coupler 76.

The syringe 86 b is interconnected with the powerhead 50 via anintermediate faceplate 102 b. A mounting 82 b is disposed on and isfixed relative to the powerhead 50 for interfacing with the faceplate102 b. A ram coupler 76 of a ram 74 (FIG. 2C), which are each part of asyringe plunger drive assembly 56 for the syringe 86 b, is positioned inproximity to the faceplate 102 b when mounted to the powerhead 50.Details regarding the syringe plunger drive assembly 56 again will bediscussed in more detail below in relation to FIG. 2C. Generally, theram coupler 76 may be coupled with the syringe plunger 90 b of thesyringe 86 b, and the ram coupler 76 and ram 74 (FIG. 2C) may be movedrelative to the powerhead 50 to move the syringe plunger 90 b along theaxis 100 b (FIG. 2A). It may be such that the ram coupler 76 is engagedwith, but not actually coupled to, the syringe plunger 90 b when movingthe syringe plunger 90 b to discharge fluid through the nozzle 89 b ofthe syringe 86 b.

The faceplate 102 b may be moved at least generally within a plane thatis orthogonal to the axes 100 a, 100 b (associated with movement of thesyringe plungers 90 a, 90 b, respectively, and illustrated in FIG. 2A),both to mount the faceplate 102 b on and remove the faceplate 102 b fromits mounting 82 b on the powerhead 50. The faceplate 102 b also may beused to couple the syringe plunger 90 b with its corresponding ramcoupler 76 on the powerhead 50. In this regard, the faceplate 102 b mayinclude a handle 106 b. Generally and with the syringe 86 b beinginitially positioned within the faceplate 102 b, the syringe 86 b may berotated along its long axis 100 b (FIG. 2A) and relative to thefaceplate 102 b. This rotation may be realized by moving the handle 106b, by grasping and turning the syringe 86 b, or both. In any case, thisrotation moves/translates both the syringe 86 b and the faceplate 102 bat least generally within a plane that is orthogonal to the axes 100 a,100 b (associated with movement of the syringe plungers 90 a, 90 b,respectively, and illustrated in FIG. 2A). Rotating the syringe 86 b inone direction moves/translates the syringe 86 b and faceplate 102 b inan at least generally downward direction to couple the syringe plunger90 b with its corresponding ram coupler 76. Rotating the syringe 86 b inthe opposite direction moves/translates the syringe 86 b and faceplate102 b in an at least generally upward direction to uncouple its syringeplunger 90 b from its corresponding ram coupler 76.

As illustrated in FIG. 2B, the syringe plunger 90 b includes a plungerbody 92 and a syringe plunger coupler 94. This syringe plunger coupler94 includes a shaft 98 that extends from the plunger body 92, along witha head 96 that is spaced from the plunger body 92. Each of the ramcouplers 76 includes a larger slot that is positioned behind a smallerslot on the face of the ram coupler 76. The head 96 of the syringeplunger coupler 94 may be positioned within the larger slot of the ramcoupler 76, and the shaft 98 of the syringe plunger coupler 94 mayextend through the smaller slot on the face of the ram coupler 76 whenthe syringe plunger 90 b and its corresponding ram coupler 76 are in acoupled state or condition. The syringe plunger 90 a may include asimilar syringe plunger coupler 94 for interfacing with itscorresponding ram coupler 76.

The powerhead 50 is utilized to discharge fluid from the syringes 86 a,86 b in the case of the power injector 40. That is, the powerhead 50provides the motive force to discharge fluid from each of the syringes86 a, 86 b. One embodiment of what may be characterized as a syringeplunger drive assembly or syringe plunger driver is illustrated in FIG.2C, is identified by reference numeral 56, and may be utilized by thepowerhead 50 to discharge fluid from each of the syringes 86 a, 86 b. Aseparate syringe plunger drive assembly 56 may be incorporated into thepowerhead 50 for each of the syringes 86 a, 86 b. In this regard andreferring back to FIGS. 2A-B, the powerhead 50 may include hand-operatedknobs 80 a and 80 b for use in separately controlling each of thesyringe plunger drive assemblies 56.

Initially and in relation to the syringe plunger drive assembly 56 ofFIG. 2C, each of its individual components may be of any appropriatesize, shape, configuration and/or type. The syringe plunger driveassembly 56 includes a motor 58, which has an output shaft 60. A drivegear 62 is mounted on and rotates with the output shaft 60 of the motor58. The drive gear 62 is engaged or is at least engageable with a drivengear 64. This driven gear 64 is mounted on and rotates with a drivescrew or shaft 66. The axis about which the drive screw 66 rotates isidentified by reference numeral 68. One or more bearings 72appropriately support the drive screw 66.

A carriage or ram 74 is movably mounted on the drive screw 66.Generally, rotation of the drive screw 66 in one direction axiallyadvances the ram 74 along the drive screw 66 (and thereby along axis 68)in the direction of the corresponding syringe 86 a/b, while rotation ofthe drive screw 66 in the opposite direction axially advances the ram 74along the drive screw 66 (and thereby along axis 68) away from thecorresponding syringe 86 a/b. In this regard, the perimeter of at leastpart of the drive screw 66 includes helical threads 70 that interfacewith at least part of the ram 74. The ram 74 is also movably mountedwithin an appropriate bushing 78 that does not allow the ram 74 torotate during a rotation of the drive screw 66. Therefore, the rotationof the drive screw 66 provides for an axial movement of the ram 74 in adirection determined by the rotational direction of the drive screw 66.

The ram 74 includes a coupler 76 that that may be detachably coupledwith a syringe plunger coupler 94 of the syringe plunger 90 a/b of thecorresponding syringe 86 a/b. When the ram coupler 76 and syringeplunger coupler 94 are appropriately coupled, the syringe plunger 90 a/bmoves along with ram 74. FIG. 2C illustrates a configuration where thesyringe 86 a/b may be moved along its corresponding axis 100 a/b withoutbeing coupled to the ram 74. When the syringe 86 a/b is moved along itscorresponding axis 100 a/b such that the head 96 of its syringe plunger90 a/b is aligned with the ram coupler 76, but with the axes 68 still inthe offset configuration of FIG. 2C, the syringe 86 a/b may betranslated within a plane that is orthogonal to the axis 68 along whichthe ram 74 moves. This establishes a coupled engagement between the ramcoupler 76 and the syringe plunger coupler 96 in the above-noted manner.

The power injectors 10, 40 of FIGS. 1 and 2A-C each may be used for anyappropriate application, including without limitation for medicalimaging applications where fluid is injected into a subject (e.g., apatient). Representative medical imaging applications for the powerinjectors 10, 40 include without limitation CT imaging, MRI, SPECTimaging, PET imaging, X-ray imaging, angiographic imaging, opticalimaging, and ultrasound imaging. The power injectors 10, 40 each couldbe used alone or in combination with one or more other components. Thepower injectors 10, 40 each may be operatively interconnected with oneor more components, for instance so that information may be conveyedbetween the power injector 10, 40 and one or more other components(e.g., scan delay information, injection start signal, injection rate).

Any number of syringes may be utilized by each of the power injectors10, 40, including without limitation single-head configurations (for asingle syringe) and dual-head configurations (for two syringes). In thecase of a multiple syringe configuration, each power injector 10, 40 maydischarge fluid from the various syringes in any appropriate manner andaccording to any timing sequence (e.g., sequential discharges from twoor more syringes, simultaneous discharges from two or more syringes, orany combination thereof). Multiple syringes may discharge into a commonconduit (e.g., for provision to a single injection site), or one syringemay discharge into one conduit (e.g., for provision to one injectionsite), while another syringe may discharge into a different conduit(e.g., for provision to a different injection site). Each such syringeutilized by each of the power injectors 10, 40 may include anyappropriate fluid (e.g., a medical fluid), for instance contrast media,a radiopharmaceutical, saline, and any combination thereof. Each suchsyringe utilized by each of the power injectors 10, 40 may be installedin any appropriate manner (e.g., rear-loading configurations may beutilized; front-loading configurations may be utilized; side-loadingconfigurations may be utilized).

FIG. 3A is a perspective view of one embodiment of a multi-doseinjection system 108. The multi-dose injection system 108 may includethe power injector 40 (the powerhead 50 of the power injector 40 isillustrated in FIG. 3A; other portions of the power injector 40 are notillustrated in FIG. 3A). The multi-dose injection system 108 may includea multi-use tubing or tube set 110 (described with reference to FIG. 4A)and a patient-specific tubing or tube set 112 (described with referenceto FIG. 4B, and which may also be characterized as a “per-patientdisposable 112”). Furthermore, the multi-dose injection system 108 mayinclude a cassette 114 (described with reference to FIGS. 5A and 5B) anda bulk fluid container holder module 116. In the multi-dose injectionsystem 108, a fluid may be transferred from the bulk fluid containerholder module 116, through the multi-use tubing set 110, through thepatient-specific tubing set 112, and into a patient (e.g., into thevasculature of the patient through a catheter 260 or the like). Themulti-dose injection system 108 may be operable to transfer and/or mixfluids from one or more bulk containers to one or more patients. In thisregard, the multi-dose injection system 108 may allow for safe and easyuse of bulk containers as well as multiple uses (e.g., across multiplepatients) of a saline syringe 126, a contrast syringe 127 and themulti-use tubing set 110.

For use in the multi-dose injection system 108, the syringes 126, 127may be provided empty. Furthermore, each syringe 126, 127 may be of anyappropriate configuration. As shown in FIG. 3A, the saline syringe 126(the syringe fluidly interconnected to a saline bottle 118) may be ofthe same configuration as the contrast syringe 127 (the syringe fluidlyinterconnected to a contrast bottle 120). Accordingly, generic emptysyringes may be supplied that are operable to be installed in either ofthe syringe mounting locations on the powerhead 50 and used as either asaline syringe 126 or a contrast syringe 127.

The bulk fluid container holder module 116 may be operable to hold thesaline bottle 118 and the contrast bottle 120 for delivery of salineand/or contrast to a single patient and/or to a plurality of patients.Such a configuration may be used, for example, in delivering contrastand saline in connection with an imaging procedure such as MRI and CTimaging. In other embodiments, the bulk fluid container holder module116 may be configured to hold any appropriate type and number of bulkcontainers. The number and/or type of bulk containers may correspond toa particular medical fluid delivery procedure. Any appropriate fluid maybe contained in each individual bulk container installed on the bulkfluid container holder module 116.

The bulk fluid container holder module 116 may be supported by a support122. The support 122 may be adjustable such that the height of the bulkfluid container holder module 116 may be adjusted. The support 122 maygenerally be adjusted such that the bulk fluid container holder module116 is disposed at a level higher than the powerhead 50. Suchpositioning allows flow from the bulk fluid container holder module 116to the powerhead 50 to be assisted by gravity. The support 122 may, forexample, be in the form of a vertical pole. The support 122 may be astand-alone unit or it may be attachable to, and supportable by, anothercomponent of the multi-dose injection system 108, such as the portablestand 48 for the powerhead 50.

The bulk fluid container holder module 116 may include two containerholders: a saline container holder 124 and a contrast container holder125. As shown in FIG. 3A, the container holders 124, 125 may correspondto the shapes of the saline bottle 118 and the contrast bottle 120,respectively. For example, as shown in FIG. 3A, the container holders124, 125 may comprise recesses to accommodate the bottle 118, 120,respectively, and the recesses may be shaped to correspond to the shapesof the bottles 118, 120. The container holders 124, 125 may cradle(e.g., support the bottles 118, 120 by contacting them with portions ofthe container holders 124, 125 that correspond to the shape of portionsof the bottles 118, 120) the containers (e.g., saline bottle 118,contrast bottle 120) disposed therein. The saline bottle 118 and thecontrast bottle 120 may, for example, each be 500 milliliter bottles orof any other appropriate size. The saline bottle 118 and the contrastbottle 120 may be held such that the openings of the bottles 118, 120are facing downward. The openings may be fluidly interconnected to thecassette 114.

While the multi-dose injection system is generally described hereinemploying the bottles 118, 120 as fluid sources, other types of fluidsources are contemplated. For example, differently shaped bottles, fluidbags and/or any other appropriate type of fluid source and/or bulk fluidcontainer may be substituted for one or both of the bottles 118, 120. Insuch embodiments, the container holders 124, 125 may be shaped tocorrespond to the different shaped bottles, fluid bags, or otherappropriate type of fluid source and/or bulk fluid container. Suchcontainers may be of any appropriate configuration, volume and/or shape.Each container holder 124, 125 may be configured to hold a bulkcontainer in a predetermined position such that a fluid outlet of thebulk container is downwardly disposed. Moreover, in systems that includemultiple container holders, each container holder may be specificallyconfigured for a particular bulk container (e.g., one or more of thecontainer holders may be configured differently from one or more othercontainer holders in a particular multi-dose injection system 108). Forexample, the saline bottle 118 may be shaped such that it is inoperableto be installed into the contrast container holder 125. Furthermore, thecontainer holders 124, 125 may be adjustable to accommodate differenttypes of bulk containers.

The bulk fluid container holder module 116 may include componentryoperable to warm one or more bulk containers disposed therein. Anyappropriate means for heating the bulk containers may be utilized. Forexample, the bulk fluid container holder module 116 may include one ormore resistive elements disposed along one or more surfaces of thecontainer holders 124, 125 such that heat generated by the one or moreresistive elements may be transferred to the bulk containers, thusheating the fluid therein. In this regard, the container holders 124,125 may cradle (e.g., surfaces of the container holders 124, 125 maycorrespond to portions of the shape of the bottles 118, 120) bottles118, 120 inserted therein, resulting in a contact area that may aid thetransfer of heat from the container holders 124, 125 to the bottles 118,120. The bulk fluid container holder module 116 may include sensorsoperable to sense the temperature of various members such as, forexample, fluid contained within the bulk containers and/or surfaces ofthe container holders 124, 125. The temperature to which the bulkcontainers may be heated may be adjustable. The bulk fluid containerholder module 116 may, for example, be operable to warm any one or moreof the bulk containers disposed therein to level at or near bodytemperature.

The bulk fluid container holder module 116 may be configured such thatthe cassette 114 may be removably and replaceably fixed to the bulkfluid container holder module 116. For example, the bulk fluid containerholder module 116 may contain features that allow the cassette 114 to besnapped into the bulk fluid container holder module 116. It may be suchthat the cassette 114 can be both detachably installed on and removedfrom the bulk fluid container holder module 116 by hand—without the useof any tools. Other types of mechanisms, such as screws, spring-loadedpins, magnets, or any other appropriate mechanism may be used toremovably and replaceably fix the cassette 114 to the bulk fluidcontainer holder module 116.

As used herein, the term “detachably installed” describes a relationshipbetween components where the components are interconnected yet retainthe ability to be detached from each other where after detaching, atleast one of the components remains in a usable condition.

The bulk fluid container holder module 116 may include one or more radiofrequency identification (RFID) tag readers capable of reading RFIDtags. The one or more RFID tag readers may be operable to read a bottleRFID tag 128 disposed on each container (e.g., both the saline bottle118 and the contrast bottle 120) installed in the bulk fluid containerholder module 116. The information read from the bottle RFID tag 128 maybe used in a plurality of different ways including, for example,verification of correct bulk container, notification of a change of abulk container, and tracking of the length of time a bulk container hasbeen connected to the bulk fluid container holder module 116. Theinformation read from the bottle RFID tag 128 may include, for example,lot number, expiration date and/or time, contents, concentration, and/orfill volume. The information read from the bottle RFID tag 128 may beforwarded to the power injector 40 and/or other devices interconnectedto the multi-dose injector injection 108. The one or more RFID tagreaders may be operable to distinguish which bottle 118, 120 is in whichcontainer holder 124, 125. In this regard, the one or more RFID tagreaders may be operable to detect a misplaced bottle (e.g., the salinebottle 118 placed in the contrast container holder 125).

The one or more RFID tag readers may be operable to read an RFID tagdisposed on the cassette 114. In this regard, the multi-dose injectionsystem 108 may be operable to determine when the cassette 114 has beenremoved and/or when a new cassette 114 has been installed. Themulti-dose injection system 108 may also be operable to determine when achange of cassette 114 is needed and may indicate such a situation(e.g., via the GUI 52 and/or via an audible alert) to an operator (e.g.,medical personnel) of the multi-dose injection system 108.

Other appropriate methods of bottle 118, 120 and/or cassette 114identification and information handling, either singularly or incooperation, may be employed by the multi-dose injection system 108. Forexample, machine-readable labels (e.g., barcodes) and/or human-readablelabels may be employed to perform some of the functions of the RFID tagsand readers discussed above.

The bulk fluid container holder module 116 may include color-codingand/or other visual indicators to aid the operator in setting up themulti-dose injection system 108. For example, the saline bottle 118 mayinclude a purple portion (e.g., on the label, attached to the bottle)that coincides with a purple portion disposed within the salinecontainer holder 124 where the saline bottle 118 is to be installed. Inthis regard, the operator may match the saline bottle 118 (that includesthe purple portion) to the saline container holder 124 (that includesthe purple portion). Similarly, the contrast bottle 120 andcorresponding contrast container holder 125 may be color-coded with, forexample, yellow features. Of course, any appropriate colors and/orsymbols may be used as visual indicators to aid the operator in settingup the multi-dose injection system 108.

Turning briefly to FIG. 5B, the cassette 114 may include a saline valve176 and a contrast valve 178. The bulk fluid container holder module 116may include valve actuators 130, 131 (FIG. 3B) operable to actuate thevalves 176, 178 of the cassette 114. Each valve 176, 178 may beactuatable by rotating a female hexagonal member associated with theparticular valve 176, 178. The valves 176, 178 may be of any appropriateconfiguration (e.g., stop-cock type valves) and operable to control theflow of fluid therethrough. In this regard, the valves 176, 178 may beoperable to be continuously adjustable from a fully closed position to afully opened position.

The bulk fluid container holder module 116 and/or the cassette 114 mayinclude features that enable the multi-dose injection system 108 todetermine the positions of the valves 176, 178 after the cassette 114has been installed onto the bulk fluid container holder module 116. Forexample, the valves 176, 178 may feature hard stops that prevent thefemale hexagonal members from freely rotating through 360 degrees.Accordingly, the valve actuators 130, 131 may drive the valves 176, 178until the valves 176, 178 bump up against the hard stops, at which timethe positions of the valves 176, 178 would be known. In another example,the cassette 114 may include switches (and associated electricalconnections) that may be actuated when the valves 176, 178 are in aparticular position (e.g., open or closed) and the multi-dose injectionsystem 108 may be able to read the actuated switches to determine theposition of the valves 176, 178. In still another example, the valves176, 178 may include indicators (e.g., visual, magnetic) as to theirposition and the bulk fluid container holder module 116 may includesensors operable to determine the position of the valves 176, 178 basedon sensing the indicators.

FIG. 3B is a perspective view of the bulk fluid container holder module116 with the cassette 114, saline bottle 118 and contrast bottle 120removed. The saline valve actuator 130 and the contrast valve actuator131 of the bulk fluid container holder module 116 may comprise hexagonalmale protrusions operable to interface with the corresponding femalehexagonal members of the corresponding valves 176, 178. The valveactuators 130, 131 may each include a motor or any other appropriatemechanism to rotate the hexagonal male protrusions to adjust the valves176, 178. Although shown in FIGS. 5B and 3B as hexagonally keyed, anyappropriate method of mechanically interfacing the valve actuators 130,131 of the bulk fluid container holder module 116 with the valves 176,178 of the cassette 114 may be incorporated into the multi-doseinjection system 108. Furthermore, any other appropriate method ofactuation of the valves 176, 178 of the cassette 114 may be utilized.

Returning to FIG. 3A, the bulk fluid container holder module 116 mayinclude one or more sensors operable to detect a fluid level within thesaline bottle 118 and/or contrast bottle 120. For example, opticalsensors may be disposed close to the opening of the saline bottle 118and/or contrast bottle 120 to detect when the saline bottle 118 and/orcontrast bottle 120 is empty or close to empty. Any appropriate type ofsensor or sensors disposed in any appropriate location or locations maybe utilized by the bulk fluid container holder module 116. The sensorsmay be disposed to generally detect fluid volume levels within theattached saline bottle 118 and/or contrast bottle 120, or the sensorsmay be disposed to detect when the volume within saline bottle 118and/or contrast bottle 120 reaches a certain level (e.g., close toempty).

The bulk fluid container holder module 116 may be operable tocommunicate with other portions of the multi-dose injection system 108.In this regard, the various features of the bulk fluid container holdermodule 116 discussed herein may be controlled by and/or directed bycomponents located in other portions of the multi-dose injection system108 (e.g., the powerhead 50 and/or GUI 52 of the power injector 40). Forexample, actuation of the valve actuators 130, 131 may be controlled by,and synchronized with, the powerhead 50. The bottle heaters of the bulkfluid container holder module 116 may be controlled by the powerhead 50(e.g., a user may turn on and off the bottle warmer(s) and set the settemperature of the bottle warmer(s) from the GUI 52). Moreover, the bulkfluid container holder module 116 may communicate RFID tag informationobtained from the bottles 118, 120 and/or cassette 114 installed intothe bulk fluid container holder module 116 to the powerhead 50 or otherappropriate component of the multi-dose injection system 108. The bulkfluid container holder module 116 may communicate fluid levelinformation (e.g., obtained from the sensors discussed above). Thecommunications between the bulk fluid container holder module 116 andother components of the multi-dose injection system 108 may be via anyappropriate method or technology, including a direct electricalconnection (e.g., wired) or a wireless connection.

The illustrated bulk fluid container holder module 116 and accompanyingdiscussion related to the bulk fluid container holder module 116describe container holders 124, 125 designated for the saline bottle 118and a contrast bottle 120. However, the bulk fluid container holdermodule 116 may be configured to hold any appropriate number ofcontainers for a particular application or procedure. For example, anembodiment of a multi-dose injection system 108 may include a singlecontainer holder for procedures where only a single fluid source isneeded. For a further example, an embodiment of a multi-dose injectionsystem 108 may include three or more container holders for procedureswhere three or more different fluid sources may be required. In still afurther example, an embodiment of a multi-dose injection system 108 mayinclude three or more container holders where some of the containerholders hold separate bulk containers containing the same type of fluid.Such a system may be used to aid in bulk container replacement and/or tobe operable to continue to deliver fluids when one of the bulkcontainers becomes empty or close to empty.

The bulk fluid container holder module 116 in conjunction with thepowerhead 50 may be operable to transfer fluids from either bottle 118,bottle 120, or from both bottle 118 and bottle 120. Such transfers maybe done sequentially or simultaneously. For example, a particularpatient may only receive contrast during a particular procedure, inwhich case contrast from the contrast bottle 120 would be loaded intothe contrast syringe 127 installed on the powerhead 50. In anotherexample, a patient may first receive a dose of saline, followed by adose of contrast (or vice versa), in which case contrast from thecontrast bottle 120 would be loaded into the contrast syringe 127installed on the powerhead 50 and saline from the saline bottle 118would be loaded into the saline syringe 126 installed on the powerhead50. In another example, a patient may receive a dose of saline andsimultaneously receive a dose of contrast, in which case contrast fromthe contrast bottle 120 could be loaded into the contrast syringe 127installed on the powerhead 50 and saline from the saline bottle 118could be loaded into the saline syringe 126 installed on the powerhead50. The two fluids may mix together in the multi-use tubing set 110,effectively delivering a diluted dose of contrast to the patient.

FIG. 4A is a perspective view of the multi-use tubing set 110 and FIG.4B is a perspective view of the patient-specific tubing set 112. Themulti-use tubing set 110, as illustrated in FIG. 4A, may be permanentlyinterconnected to the cassette 114. In this regard, the multi-use tubingset 110 and the cassette 114 may be packaged together and replaced as asingle unit. Alternatively, the cassette 114 and the multi-use tubingset 110 may be separate items that may be interconnected to each other(e.g., using Luer connectors, barbs).

Fluidly interconnected to the cassette 114 are two fluid tubes: a salinetube 132 and a contrast tube 134. The tubes 132, 134 may be of anyappropriate construction for directing the flow of fluid between variouslocations. The tubes 132, 134 may fluidly interconnect the cassette 114with the corresponding nozzles of the syringes 126, 127 on the powerhead50. In this regard, the saline tube 132 may be fluidly interconnected toa saline connector 142. The saline connector 142 may be in the form of aLuer type connector operable to directly connect to the nozzle of thesaline syringe 126 on the powerhead 50. The contrast tube 134 may befluidly interconnected to a contrast connector 144. The contrastconnector 144 may be in the form of a Luer type connector operable todirectly connect to the nozzle of the contrast syringe 127 on thepowerhead 50. For the connections between the saline tube 132 and thecontrast tube 134 and their corresponding nozzle, any appropriate fluidconnector may be substituted for the Luer connectors described herein.

The saline tube 132 may be interconnected to the saline connector 142via a saline Y connector 138 (or any other appropriate connector), orthe saline connector 142 may simply be associated with a short extensiontube that leads into the saline tube 132. The saline Y connector 138 mayalso be fluidly interconnected to a saline and contrast tubes Yconnector 150. Positioned between the saline Y connector 138 and thesaline and contrast tubes Y connector 150 may be a saline tube one-waycheck valve 146. The saline tube one-way check valve 146 may be operableto only permit fluid flow in the direction from the saline Y connector138 to the saline and contrast tubes Y connector 150. The saline tubeone-way check valve 146 may require a pressure equal to or greater thana cracking pressure (e.g., the minimum upstream pressure at which thesaline tube one-way check valve 146 will operate) to be present upstreamof the saline tube one-way check valve 146 before the saline tubeone-way check valve 146 will open and allow fluid to flow. Similarly,the contrast tube 134 may be interconnected to the contrast connector144 via a contrast Y connector 140 (or any other appropriate connector),or the contrast connector 144 may simply be associated with a shortextension tube that leads into the contrast tube 134. The contrast Yconnector 140 may also be fluidly interconnected to the saline andcontrast tubes Y connector 150. Positioned between the contrast Yconnector 140 and the saline and contrast tubes Y connector 150 may be acontrast tube one-way check valve 148. The contrast tube one-way checkvalve 148 may be configured similarly to the saline tube one-way checkvalve 146 and may be operable to only permit fluid flow in the directionfrom the contrast Y connector 140 to the saline and contrast tubes Yconnector 150. Together the saline tube one-way check valve 146 andcontrast tube one-way check valve 148 permit fluid to flow from thesaline syringe 126 and contrast syringe 127 of the powerhead 50 to thepatient, while at least attempting to prevent backflow in the oppositedirection.

As illustrated in FIG. 4A, the saline tube 132 and the contrast tube 134may be joined together (although not fluidly joined together) in ajoined tube section 136. Such an arrangement helps to reduce tangling oftubes such as may occur if the saline tube 132 and the contrast tube 134were completely separate from each other. The saline tube 132 and theContrast tube 134 may be of any appropriate length. For example, thetubes 132, 134 may be of a length such that the cassette 114, attachedto the bulk fluid container holder module 116, may be positioned abovethe powerhead 50 such that gravity may aid in the flow of saline andcontrast from the bulk fluid container holder module 116 down to thepowerhead 50.

The saline tube 132 may be configured with an internal diameterappropriate for the viscosity of saline and the flow rate and pressureexpected therein during medical fluid delivery procedures. Furthermore,the saline tube 132 wall thickness and material of the saline tube 132may be selected, inter alia, based on expected pressures during fluiddelivery procedures. Similarly, the contrast tube 134 may be configuredwith an internal diameter appropriate for the viscosity of the contrastto be used and the flow rate and pressure expected therein duringmedical fluid delivery procedures. The contrast tube 134 wall thicknessand material of the contrast tubes 134 may be selected, inter alia,based on expected pressures during fluid delivery procedures.

The saline connector 142 and the contrast connector 144 may becolor-coded or otherwise marked to aid in the setting up of themulti-dose injection system 108. For example, continuing the colorscheme discussed above with respect to the marking of the saline bottle118, the saline connector 142 may be color-coded purple. Furthermore thenozzle and/or other portion of the saline syringe 126 on the powerhead50 may also be color-coded purple. Along these same lines, the contrastconnector 144 and the corresponding nozzle and/or other portion of thecontrast syringe 127 on the powerhead 50 may be color-coded yellow.Furthermore, the saline connector 142 and the contrast connector 144 maybe uniquely configured (e.g., uniquely keyed, uniquely sized) such thateach of the connectors 142, 144 is only operable to be attached to itscorresponding nozzle from the corresponding syringe 126, 127.

Interconnected to the saline and contrast tubes Y connector 150 may bean extension tube 152. The extension tube 152 may be coiled to aid inthe handling of the extension tube 152 and to reduce tangling. Theextension tube 152 may be of any appropriate length. For example, theextension tube 152 may be of a length to accommodate the typicaldistance between the powerhead 50 and the patient-specific tubing set112 that may be seen before, during, and after an imaging procedureutilizing the multi-dose injection system 108.

At the end of the extension tube 152 opposite from the saline andcontrast tubes Y connector 150 may be a needle-free swabable female Luerconnector 154. Catheters, such as catheter 260 (FIG. 3A), inserted intoa patient typically have a female Luer connector (e.g., catheterinterface female Luer 262). By having a female Luer connector 154 at theend of the extension tube 152, accidental attachment of the female Luer154 directly to a catheter installed in a patient should be prevented(e.g., due to the inability of the catheter interface female Luer 262,connected to the catheter 260, to directly connect to the female Luerconnector 154 at the end of the extension tube 152). Thus, the chancesof contaminating the multi-use tubing set 110 with patient fluids shouldbe reduced. In this regard, a unique tubing set with male Luerconnectors on each end, such as the patient-specific tubing set 112described below, is required to interconnect the extension tube 152 tothe catheter interface female Luer 262. Furthermore, the female Luerconnector 154 is swabable and therefore may be cleaned before beingfluidly interconnected to a new patient-specific tubing set 112.

As noted, and referring now to FIG. 4B, the patient-specific tubing set112 may include two male luer connections: a male Luer 156 operable tointerconnect to the female Luer 154 (from the multi-use tubing set 110)and a patient interface male Luer 162 operable to interconnect to, forexample, the catheter interface female Luer 262 and the catheter 260(FIG. 3A) inserted into the patient. The patient-specific tubing set 112may include an alternate access port such as access Luer 158. The accessLuer 158 may be used, for example, to check the patency of the catheter260 inserted into the patient and connected via the patient interfacemale Luer 162. The access Luer 158 may be used to, for example, deliveralternate fluids (e.g., alternate to the saline or contrast) to thepatient. The access Luer 158 may be used for any other appropriateprocedure and/or fluid delivery. Any other appropriate type of fluidaccess device may be added to or substituted for the access Luer 158.

The patient-specific tubing set 112 may also include dual one-way checkvalves 160. The dual one-way check valves 160 may prevent fluid flow ina direction from the patient interface male Luer 162 toward the maleLuer 156. In this regard, the dual one-way check valves 160 may reducethe potential for contamination of the multi-use tubing set 110 withfluids from the patient. This then should enable the use of themulti-use tubing set 110 to supply fluid to several patients by reducingthe potential of fluid from a particular patient mixing with fluids fromanother patient. The dual one-way check valves 160 may comprise twoserially-disposed individual one-way check valves. Such an arrangementprovides a level of redundancy in that if one of the one-way checkvalves fails, the other one-way check valve may remain functional andreduce the potential of backflow of fluids from the patient into themulti-use tubing set 110.

The dual one-way check valves 160 of the patient-specific tubing set 112are positioned downstream (e.g., relative to the normal flow of fluidsthrough the patient-specific tubing set 112) of a Y connector 164. Inalternate configurations, the dual one-way check valves 160 may bedisposed upstream of the Y connector 164 between the Y connector 164 andthe male Luer 156. In another arrangement, one one-way valve of the dualone-way check valves 160 may be disposed on each side of the Y connector164. Any other appropriate configuration of the one-way check valves ofthe dual one-way check valves 160 may be utilized in thepatient-specific tubing set 112.

Returning briefly to FIG. 3A, the patient-specific tubing set 112 may befluidly interconnected to the catheter 260 that may be inserted into thepatient. In this regard, the catheter interface female Luer 262 may beoperable to fluidly connect to the patient interface male Luer 162. Thecatheter 260 may include a fluid outlet port 261 through which fluidfrom the multi-dose injection system 108 may flow into the vasculatureof a patient and thereafter mix with fluids of the patient.

FIG. 5A is a perspective top view of the cassette 114 used by themulti-dose injection system 108. FIG. 5B is a perspective bottom view ofthe cassette 114 of FIG. 5A. The cassette 114 may be selectivelysecurable to the bulk fluid container holder module 116. The cassette114 may include features that correspond to features on the bulk fluidcontainer holder module 116 so that the cassette 114 may be secured tothe bulk fluid container holder module 116. For example, the cassette114 may snap into the bulk fluid container holder module 116. Clips,screws or the like may be used to secure the cassette 114. Any otherappropriate means of selectively securing the cassette 114 to the bulkfluid container holder module 116 may be employed.

The cassette 114 may include an identification feature such as acassette RFID tag 174. The bulk fluid container holder module 116 mayinclude an RFID tag reader (not shown) operable to read the RFID tag 174attached to the cassette 114. In this regard, the bulk fluid containerholder module 116 may be operable to determine information regarding thecassette 114. Such information may include, for example, cassette 114part number, cassette 114 serial number, and cassette 114 configurationinformation. Such information may be communicated to other components ofthe multi-dose injection system 108. Such information may, for example,be used for operational, validation, or recordation purposes.Furthermore, using the cassette RFID tag 174 to track the presence ofthe cassette 114 attached to the bulk fluid container holder module 116and tracking the flow of fluid from the bulk fluid containersinterconnected to the cassette 114, a usage history of the cassette 114may be developed. Such a usage history may be used to determine, forexample, when to replace the cassette 114 (and optionally also themulti-use tubing set 110 connected to the cassette 114) and/or when toreplace the saline bottle 118 and/or contrast bottle 120. Moreover, theRFID tag reader may be operable to detect when a particular cassette 114is removed and/or replaced with a different cassette 114.

The cassette RFID tag 174 may be disposed in any appropriate location onthe cassette 114. The RFID tag reader may be disposed in any appropriatelocation on the bulk fluid container holder module 116 or on any otherappropriate component of the multi-dose injection system 108.

As illustrated, the cassette 114 includes two bulk fluid container fluidinterfaces in the form of a saline spike 170 and a contrast spike 172.The spikes 170, 172 may be vented to allow air to flow into the bottles118, 120 as fluid flows out of the bottles 118, 120. Where appropriate,for example where the bulk fluid containers are collapsible, the spikes170,172 may not include vents. The cassette 114 may include anappropriate number of bulk fluid container fluid interfaces. The spikes170, 172 may be fixedly secured to the cassette 114 and disposed suchthat they are pointing upward from the cassette 114 when the cassette114 is secured to the bulk fluid container holder module 116. In thisregard, fluid containers such as the saline bottle 118 (FIG. 3A) may befluidly interconnected to the cassette 114 by pressing and/or loweringthe saline bottle 118 onto the saline spike 170. The fluidinterconnection may be achieved by the saline spike 170 piercing aseptum or other pierceable barrier of the saline bottle 118 as thesaline bottle 118 is lowered onto the saline spike 170. The salinebottle 118 may be removed from the cassette 114 by pulling upward on thesaline bottle 118. Additionally, when fluidly interconnected to thesaline spike 170, additional securement features, such as clips, twistlocks, snaps, or any other appropriate securement device or devices, maybe used to further secure the saline bottle 118 onto the saline spike170. The contrast bottle 120 may be secured to the contrast spike 172 ina similar manner.

The saline spike 170 may be fluidly interconnected to the saline valve176 that is in turn fluidly interconnected to the saline tube 132. Thesaline valve 176 may be a stop-cock type valve operable to vary betweena fully open (e.g., no restriction to fluid flow between the salinespike 170 and the saline tube 132) and a fully closed (e.g., no flowbetween the saline spike 170 and the saline tube 132) position. Thesaline valve 176 may also be operable to be positioned in intermediatepositions allowing partial fluid flow therethrough. The saline valve 176may be disposed within a housing 115 of the cassette 114. The housing115 may also contain a portion of the saline spike 170 and fluidpassages fluidly interconnecting the saline tube 132 to the saline valve176 and the saline spike 170 to the saline valve 176. The contrast spike172 and the contrast tube 134 may be fluidly interconnected to asimilarly configured contrast valve 178. The contrast valve 178 may beconfigured similarly to the saline valve 176.

The cassette 114 may include saline indicia 180 to assist the user indetermining the proper location for installation of the saline bottle118. The saline indicia 180 may be in the form of a symbol, such as theletter S. Furthermore, the saline indicia 180 may be color-coded purple(or any other appropriate color). The cassette 114 may include contrastindicia 182, such as the letter C. The contrast indicia 182 may becolor-coded yellow (or any other appropriate color).

Valve 176, 178 operation will be now be described in the exemplaryconfiguration where the contrast valve 178 is fluidly interconnected tothe contrast syringe 127 on the powerhead 50. It will be appreciatedthat the flow of saline may be controlled in a similar manner and that aparticular fluid source (e.g., saline bottle 118, contrast bottle 120)may be fluidly interconnected to any appropriate syringe 126, 127 on thepowerhead 50. The contrast valve 178 may be used in conjunction with themovement of the contrast syringe 127 on the powerhead 50 to achieve thetransfer of contrast from the contrast bottle 120 through the cassette114, the multi-use tubing set 110, the patient-specific tubing set 112and into the patient. To achieve such a flow, the contrast valve 178 maybe disposed in an open position during the retraction of a plunger ofthe contrast syringe 127. During such retraction, a vacuum force may begenerated in the contrast syringe 127 and communicated to the attachedcontrast tube 134, thereby loading fluid from the contrast bottle 120into the contrast syringe 127. The contrast tube one-way check valve 148may prevent fluid from portions of the multi-use tubing set 110downstream of the contrast tube one-way check valve 148 from flowinginto the contrast syringe 127. Once a satisfactory amount of fluid hasbeen loaded into the contrast syringe 127, the contrast valve 178 may beclosed and the plunger of the contrast syringe 127 may be advanced. Theclosed contrast valve 178 may prevent contrast from flowing back intothe contrast bottle 120. Meanwhile, the contrast tube one-way checkvalve 148 may permit flow therethrough from the contrast syringe 127into the extension tube 152, the patient-specific tubing set 112 andinto the patient. Similar manipulation of the saline valve 176 and thecorresponding saline syringe 126 of the powerhead 50 may be operable tofacilitate transfer of saline from the saline bottle 118 into thepatient.

The valves 176, 178 may include features to facilitate their actuationby the bulk fluid container holder module 116. As illustrated in FIG.5B, valves 176, 178 may each include a female hex. Such female hexes maybe operable to interface with corresponding male hex protrusions (notshown) of the bulk fluid container holder module 116. The male hexprotrusions may engage with the female hexes on the cassette 114 as thecassette 114 is inserted into the bulk fluid container holder module116. Accordingly, the bulk fluid container holder module 116 may includemembers (e.g., motors) operable to drive (e.g., rotate) the male hexprotrusions in order to actuate (e.g., open, close) the valves 176, 178.Such actuation of the valves 176, 178 may be controlled by a controlmember (e.g., hardware and/or software) disposed in any appropriatecomponent or combination of components of the multi-dose injectionsystem 108. For example, the control member may be disposed within thepowerhead 50. Thus synchronization between movement of the plungers ofthe syringes 126, 127 on the powerhead 50 and the positions of thevalves 176, 178 may be achieved. Any other appropriate means ofactuating the valves 176, 178 may be utilized by the multi-doseinjection system 108. For example: protrusions shaped differently thanhexes may be used; the locations of the male and female protrusions maybe reversed; other types of interfaces such as a magnetic interface maybe used; or the cassette 114 may include valve position driving members(e.g., motors) and may be controlled through an electronic interface(e.g., electrical contacts) between the bulk fluid container holdermodule 116 and the valves 176, 178.

FIG. 6 is a flowchart of a method 190 of delivering medical fluid to aplurality of patients from the multi-dose injection system 108. Thefirst step 192 in the method 190 may be to communicatively interconnectthe bulk fluid container holder module 116 to an injection device (e.g.,powerhead 50) via a communications link. The communications link may bea hardwired electrical cable, a wireless connection, or any otherappropriate communications link. The remainder of the present method 190is described in the context of delivering saline using the salinesyringe 126 on the powerhead 50 and contrast using the contrast syringe127 on the powerhead 50. It will be appreciated that the syringes 126,127 may be reversed or that, in other embodiments, other types of fluidsmay be delivered.

The following step 194, may be to attach a new multi-use tubing set 110to the bulk fluid container holder module 116 and the powerhead 50. Themulti-use tubing set 110 may be pre-connected to the cassette 114. Thisattachment may include inserting the cassette 114 into a correspondingreceiving location in the bulk fluid container holder module 116. Thenext portion of the current step 194 may be to interconnect the salineconnector 142 to the corresponding nozzle of the saline syringe 126 ofthe powerhead 50. This may be followed by interconnecting the contrastconnector 144 to the nozzle of the contrast syringe 127. The currentstep 194 may also include reading the cassette RFID tag 174 with an RFIDtag reader. The multi-dose injection system 108 may verify that thecorrect cassette 114 has been installed for the procedure to beperformed by the multi-dose injection system 108. Furthermore, thecurrent step 194 may include determining the position of the valves 176,178 by the multi-dose injection system 108 using the components of thebulk fluid container holder module 116 and/or the cassette 114 discussedabove. The current step 194 may also include actuating the valves 176,178 such that they are in a predetermined configuration (e.g., closed toprevent flow between the bottles 118, 120 and the multi-use tubing set110).

This may be followed by the step 196 of fluidly attaching the salinebottle 118 and the contrast bottle 120 to the cassette 114. The user maybe aided in this step 196 by color-coding on the bottles 118, 120,container holders 124, 125, and/or the cassette 114. For example, thesaline bottle 118, the saline container holder 124, and saline indicia180 indicator on the cassette 114 may all be color-coded purple toassist the user. Similarly, contrast-related components may becolor-coded yellow. Any other appropriate color-coding scheme may beused. The attaching of the bottles 118, 120 may comprise lowering thebottles 118, 120 onto corresponding spikes 170, 172 of the cassette 114.

The next step 198 may be to warm the fluids in the bottles 118, 120.This may be accomplished by energizing resistive heating elementsdisposed in the container holders 124, 125. The fluids in the bottles118, 120 may be heated to a preset temperature (e.g., the internaltemperature of the patient who is to receive the fluids). Alternatively,any appropriate method of heating fluid within the bottles 118, 120 maybe used. The bottles 118, 120 may be heated to any appropriate targettemperature. The bottles 118, 120 may each be heated to the sametemperature, or each bottle 118, 120 may be heated to a different targettemperature.

The next step, step 200, may include attaching the patient-specifictubing set 112 to the multi-use tubing set 110. This may includeswabbing (e.g., with an alcohol swab) the swabable female Luer connector154 of the multi-use tubing set 110 to clean and/or sterilize the femaleLuer connector 154. This may be followed by interconnecting the swabablefemale Luer connector 154 to the male Luer 156.

The next step 202 may be to initialize fluid delivery components (e.g.,the syringes 126, 127, the tubing of the multi-use tubing set 110, andthe patient-specific tubing set 112). This step 202 may includeorienting the powerhead 50 such that it is pointing upward (e.g., so thenozzles of the syringes 126, 127 are pointing upward). Next the valves176, 178 may be opened and the plungers of the syringes 126, 127retracted to load fluid from the bottles 118, 120 into the multi-usetubing set 110 and into the syringes 126, 127. The air within thesyringes 126, 127 may accumulate at the top of the syringes 126, 127.Next, the valves 176, 178 may be closed and the plungers of the syringes126, 127 extended to force the air and fluid within the syringes 126,127 past the one-way check valves 146, 148, through the extension tube152, and through the patient-specific tubing set 112. This process maybe repeated until at least substantially all air has been expelled fromthe tubing through the patient interface male Luer 162. The saline tube132 and the contrast tube 134 may be individually or simultaneouslypurged using such a process. Moreover, the multi-use tubing set 110could be purged prior to attaching the patient-specific tubing set 112(which would thereafter have to be purged). The multi-use tubing set 110should not have to be re-purged until the bottles 118, 120 are replaced,or until the multi-use tubing set 110 is replaced, although thepatient-specific tubing set 112 should be purged each time it isreplaced.

The next step 204 may be to connect the patient interface male Luer 162of the patient-specific tubing set 112 to a corresponding female Luer(e.g., catheter interface female Luer 262) interconnected to thecatheter 260 that has been inserted into the patient. The patency of thecatheter 260 may then be verified through the access Luer 158.

The next step 206 may be to inject fluid from the multi-dose injectionsystem 108 to the patient through the fluid outlet port 261 of thecatheter 260. This may include placing the powerhead 50 in adownward-pointing position. In this regard, any air within the syringes126, 127 or any air that enters the syringes 126, 127 may be trappedwithin the syringes 126, 127.

The remainder of step 206 and the method 190 will be described in thecontext of injecting contrast into the patient using the contrastsyringe 127 on the powerhead 50. It should be understood that theprocedure for injecting saline may be similar. Furthermore, eithersyringe 126, 127 of the powerhead 50 may be used for the injection ofany appropriate fluid.

Continuing with step 206, the contrast valve 178 may be opened and theplunger of the contrast syringe 127 may be retracted to load contrastfrom the contrast bottle 120 into the contrast syringe 127. During thisstep, the contrast tube one-way check valve 148 should prevent fluiddownstream of the contrast tube one-way check valve 148 from enteringthe contrast syringe 127. Next, the contrast valve 178 is closed and theplunger of the contrast syringe 127 is extended. The closed contrastvalve 178 should prevent fluid from flowing into the contrast bottle 120and the contrast tube one-way check valve 148 permits flow therethroughas the pressure in the contrast tube 134 elevates due to the movement ofthe plunger of the contrast syringe 127. In this regard, contrast mayflow past the contrast tube one-way check valve 148, into the extensiontube 152, through the patient specific tubing set 112, through thecatheter 260, and into the patient.

The sequence of contrast valve 178 opening and closing coupled withretraction and extension of the plunger of the contrast syringe 127 maybe repeated until the patient has received a predetermined dose ofcontrast. Accordingly, the next step 208 may be to inquire/determine ifthe patient has received the full desired dose of contrast. If thepatient has not received the full dose, the step 206 of injectingcontrast may continue. If the patient has received the full dose, thenext step 210 may be to stop the injection process. It should beappreciated that an injection protocol for a particular patient mayutilize any appropriate number of phases, and that each phase may useany appropriate fluid (e.g., an injection protocol may entailalternating injections of contrast and saline, may include at least oneinjection of contrast and at least one injection of saline, or thelike).

Once the injection process has been stopped, the next step 212 may be todisconnect the multi-use tubing set 110 from the patient-specific tubingset 112 by disconnecting the swabable female Luer connector 154 from themale Luer 156.

The next step 214 may be to determine if the saline bottle 118 andcontrast bottle 120 contain enough fluid for performance of fluiddelivery to a subsequent patient. If it is determined that the salinebottle 118, the contrast bottle 120, or both need to be replaced, thenext step 215 may be to load any fluid contained in the bottle 118and/or 120 to be replaced into the appropriate syringe 126 and/or 127.In this regard, the fluid may be available for injection into the nextpatient. The next step 216 may be to remove the appropriate bottle andmove on to step 196 and fluidly attach a new bottle. The process 190 maythen be continued for the subsequent patient using a newpatient-specific tubing set 112. If it is determined that the bottles118, 120 do not need to be replaced, the next step in the process 190may be to move to step 200 and continue the process on the subsequentpatient using a new patient-specific tubing set 112.

Once it is determined that the multi-use tubing set 110 is to bereplaced, the process 190 may be halted and the multi-use tubing set 110replaced. The used multi-use tubing set 110 may then be discarded orrefurbished (e.g., cleaned and/or sterilized). The determination thatthe multi-use tubing set 110 is to be replaced may, for example, bebased on a predetermined length of time that the multi-use tubing set110 has been in service, a predetermined volume of fluids movingtherethrough, suspected contamination and/or damage, or any otherappropriate criteria.

The multi-dose injection system 108 may also be operable to performcertain functions related to the changing of the saline bottle 118and/or contrast bottle 120. For example, when the contrast bottle 120 isnear empty, the powerhead 50 may load any remaining contrast into thecontrast syringe 127. The user may then replace the contrast bottle 120.The plunger of the contrast syringe 127 may then be extended with thecontrast valve 178 open so that any air in the contrast tube 134 isforced into the new contrast bottle 120. Thus, the purge step 202 may beavoided or the amount of purging required may be reduced. In thisregard, the contrast bottle 120 may be expandable, have an air pocket,or have any other appropriate feature (e.g., a vent) to allow fluids tobe forced therein from the contrast syringe 127.

Additionally, when not injecting fluids into a patient, one or both ofthe saline valve 176 and the contrast valve 178 may be left in an openposition. This may prevent undesired pressure from being built up in thesyringes 126, 127 of the powerhead 50.

FIG. 7 presents another embodiment of an injection system 220 (e.g., amulti-dose injection system; a medical fluid injection system; amulti-dose medical fluid injection system). A first fluid source 222 isfluidly interconnected with a first injection device 226 by first fluidsource tubing 224. A second fluid source 228 is fluidly interconnectedwith a second injection device 232 by second fluid source tubing 230.Any appropriate fluid may be utilized by each of the first fluid source222 and the second fluid source 228. In one embodiment, the first fluidsource 222 utilizes contrast media, while the second fluid source 228utilizes saline or any other appropriate biocompatible flushing media.Each of the first fluid source 222 and the second fluid source 228 mayhave a fluid volume that is sufficient for multiple injections orinjection procedures (e.g., for multiple patients).

The first injection device 226 and the second injection device 232 eachmay be of any appropriate size, shape, configuration, and/or type (e.g.,a power injector). The first fluid source tubing 224 and the secondfluid source tubing 230 each may be in the form of any appropriateconduit (e.g., medical tubing). Any appropriate component or combinationof components may be incorporated in either one or each of the firstfluid source tubing 224 and the second fluid source tubing 230 (e.g.,one or more valves of any appropriate type).

A multi-use or multi-patient tubing set 234 is fluidly interconnectedwith each of the injection devices 226, 232. There are three differentparts or sections of the multi-patient tubing set 234—first injectiondevice tubing 236 that extends from the first injection device 226,second injection device tubing 238 that extends from the secondinjection device 232, and common discharge tubing 240. Fluid dischargedfrom the first injection device 226 is directed into the first injectiondevice tubing 236, and then into the common discharge tubing 240. Fluiddischarged from the second injection device 232 is directed into thesecond injection device tubing 238, and then into the common dischargetubing 240.

The first injection device tubing 236, the second injection devicetubing 238, and the common discharge tubing 240 may be integrallyformed, or one or more appropriate connectors may be utilized to fluidlyinterconnect adjacent sections of the multi-patient tubing set 234. Anappropriate connector may be used to install the first injection devicetubing 236 to the first injection device 226, while an appropriateconnector may be used to install the second injection device tubing 238to the second injection device 232. A connector 242 of any appropriatetype may be provided at a free end of the common discharge tubing 240.

A disposable, single-use, single-patient, or patient-specific tubing set244 is fluidly interconnected with the common discharge tubing 240 ofthe multi-patient tubing set 234 by a connector 246 of any appropriatetype. The single-patient tubing set 244 includes tubing 248. Anappropriate vasculature access device (e.g., a catheter) 250 may beappropriately interconnected with the tubing 248 (e.g., via anappropriate connector).

Any appropriate component or combination of components may beincorporated in either one or each of the multi-patient tubing set 234and the single-patient tubing set 244 (e.g., one or more valves of anyappropriate type). The tubing utilized by each of the multi-patienttubing set 234 and the single-patient tubing set 244 may be of anyappropriate type (e.g., medical tubing).

FIG. 8 presents another embodiment of an injection system 260 (e.g., amulti-dose injection system; a medical fluid injection system; amulti-dose medical fluid injection system). The injection system 260includes a first fluid source 262, a second fluid source 266, a powerinjector 270, a reusable or multi-patient tubing set 276, and theabove-discussed single-patient tubing set 244. The first fluid source262 is fluidly interconnected with a first syringe 272 installed on thepower injector 270 by first fluid source tubing 278 (which may be partof the multi-patient tubing set 276). The second fluid source 266 isfluidly interconnected with a second syringe 274 installed on the powerinjector 270 by second fluid source tubing 280 (which may be part of themulti-patient tubing set 276). Any appropriate fluid may be utilized byeach of the first fluid source 262 and the second fluid source 266. Inone embodiment, the first fluid source 262 utilizes contrast media,while the second fluid source 266 utilizes saline or any otherappropriate biocompatible flushing media. Each of the first fluid source262 and the second fluid source 266 may have a fluid volume that issufficient for multiple injections or injection procedures (e.g., formultiple patients). The first fluid source tubing 278 and the secondfluid source tubing 280 each may be in the form of any appropriateconduit (e.g., medical tubing). Any appropriate component or combinationof components may be incorporated in either one or each of the firstfluid source tubing 278 and the second fluid source tubing 280 (e.g.,one or more valves of any appropriate type).

The multi-patient tubing set 276 includes first syringe tubing 282 thatextends from the first syringe 272 on the power injector 270, secondsyringe tubing 284 that extends from the second syringe 274 on the powerinjector 270, and common discharge tubing 286. Fluid discharged by thepower injector 270 from the first syringe 272 is directed into the firstsyringe tubing 282, and then into the common discharge tubing 286. Fluiddischarged by the power injector 270 from the second syringe 274 isdirected into the second syringe tubing 284, and then into the commondischarge tubing 286.

The first fluid source tubing 278, the second fluid source tubing 280,the first syringe tubing 282, the second syringe tubing 284, and thecommon discharge tubing 286 may be integrally formed, an appropriateconnector may be utilized to fluidly interconnect each pair of adjacentsections of the multi-patient tubing set 276, or part of themulti-patient tubing set 276 may be integrally formed with one or moreother portions of the multi-patient tubing set 276 being incorporated byone or more connectors. An appropriate connector may be used to installthe first syringe tubing 282 to the first syringe 272, while anappropriate connector may be used to install the second syringe tubing284 to the second syringe 274. A connector 290 of any appropriate typemay be provided at a free end of the common discharge tubing 286.

Any appropriate component or combination of components may beincorporated in either one or each of the multi-patient tubing set 276and the single-patient tubing set 244 as previously noted (e.g., one ormore valves of any appropriate type). For instance, each of the firstsyringe tubing 282 and the second syringe tubing 284 may include anappropriate valve 288 (e.g., a stopcock) to allow fluid from the fluidsources 262, 266 to be loaded into the respective syringes 272, 274without being directed into the single-patient tubing set 244. Thetubing utilized by the multi-patient tubing set 276 may be of anyappropriate type (e.g., medical tubing).

The single-patient tubing set 244 used by each of the injection systems220, 260 may be in the form, or at least utilize, the above-notedpatient specific tubing set 112 of FIG. 4B. The single-patient tubingset 244 may also be in the form of, or at least may utilize, thesingle-patient tubing set 300 illustrated in FIGS. 9A-C, and which willnow be addressed (e.g., the single-patient-tubing set 300 may or may notdefine the entirety of the single-patient tubing set 244).

The single-patient tubing set 300 of FIGS. 9A-C includes tubing 302 ofany appropriate type (e.g. medical tubing). An appropriate connector 310a, 310 b is provided on each end of the single-patient tubing set 300. Amulti-patient tubing set (e.g., 234, 276) may be interconnected with thesingle-patient tubing set 300 by the connector 310 a, while avasculature access device (e.g., 250) may be interconnected with thesingle-patient tubing set 300 by the connector 310 b. The single-patienttubing set 300 may define any portion of the single-patient tubing set244 (including the tubing set 112), or could define the entiretythereof. As such, the connectors 310 a, 310 b could interface withconnectors other than those noted above (e.g., the single-patient tubingset 300 could define an end segment of the multi-patient tubing set 244at its multi-patient tubing set end; the single-patient tubing set 300could define an end segment of the multi-patient tubing set 244 at itsvasculature access device end; the single-patient tubing set 300 coulddefine an intermediate segment of the multi-patient tubing set 244).

The single-patient tubing set 300 includes a pair of check valves 304that are disposed in series along the tubing 302. Each of the checkvalves 304 allow a fluid flow through the single-patient tubing set 300in the direction indicated by the arrows in FIG. 9A (e.g., a flow fromthe connector 310 a to the connector 310 b). The check valves 304 eachcould be disposed at any appropriate location between the connectors 310a, 310 b, and need not be adjacent to one another as illustrated. One ormore access ports may be provided for the single-patient tubing set 300,for instance via a needle-free valve 308 and an appropriate connector306 (e.g., to allow a syringe to direct fluid into the single-patienttubing set 300).

The single-patient tubing set 300 also incorporates what may becharacterized as a “use” indicator 320. Generally, this use indicator320 provides a visual indication that the single-patient tubing set 300has been used. Use indicator 320 includes a housing 322 and a piston 340that is movably disposed within the housing 322. A flowpath 324 extendsthrough the housing 322, and includes an inlet port 326, an outlet port328, and an inner chamber 330. The tubing 302 may be mounted tooppositely disposed plugs through which the inlet port 326 and theoutlet port 328 extend.

The piston 340 is movably disposed within the housing 322, and includesa head 342. This head 342 interfaces with the inner chamber 330.Therefore, the head 342 of the piston 340 is exposed to the flowpath 324(e.g., interfaces with the flowpath; fluid in the flowpath 324contacts/interfaces with the head 342). The development of a certainfluid pressure within the inner chamber 330 will cause the piston 342 tomove from the position illustrated in FIGS. 9A and 9C, to the positionillustrated in FIG. 9B. Note that in the FIG. 9A/9C configuration, anend surface 344 of the piston 340 may be flush with or recessed relativeto (e.g., spaced inwardly) an end surface 334 of the housing 322 that isdisposed about the perimeter of the piston 340. In the deployed positionof FIG. 9B, the end surface 344 of the piston 340 is now disposed beyondthe end surface 334 of the housing 322 (e.g., a protruded or extendedposition for the piston 340). The housing 322 may incorporate a detent332 or any other appropriate locking mechanism (e.g., a snap-lock typefeature) to retain the piston 340 in its protruded position, once theposition has moved from the position of FIGS. 9A and 9C to the protrudedposition of FIG. 9B. As such, the use indicator 320 may be characterizedas a pop-up or pop-out indicator 320. In one embodiment, a minimumpressure of 15 psi is required to move the piston 340 to the protrudedor extended position of FIG. 9B. Other minimum pressure values may beappropriate.

There are a number of observations that may be made in relation the useindicator 320. The use indicator 320 may provide a visual indicationthat the single-patient tubing set 300 has been used in an injectionprotocol—more specifically that the single-patient tubing set 300 hasbeen exposed to at least a certain pressure. The pressure at which theuse indicator 320 responds could be set or established in anyappropriate manner.

A single response may be induced when the use indicator 320 is exposedto a certain pressure in the flowpath 324—the piston 340 moves. Thismovement of the piston 340 may be into an open space—the movement is notundertaken for purposes of having the piston 340 engage anotherstructure (“another” being in relation to the use indicator 320 as awhole) to provide an additional response. The piston 340 may move alongan axial path to provide a visual indication that the single-patienttubing set 300 has been used. The piston 340 may also be characterizedas being movable orthogonally to a fluid flowing through the useindicator 320 (specifically through the flowpath 324).

The foregoing description of the present invention has been presentedfor purposes of illustration and description. Furthermore, thedescription is not intended to limit the invention to the form disclosedherein. Consequently, variations and modifications commensurate with theabove teachings, and skill and knowledge of the relevant art, are withinthe scope of the present invention. The embodiments describedhereinabove are further intended to explain best modes known ofpracticing the invention and to enable others skilled in the art toutilize the invention in such, or other embodiments and with variousmodifications required by the particular application(s) or use(s) of thepresent invention. It is intended that the appended claims be construedto include alternative embodiments to the extent permitted by the priorart.

What is claimed:
 1. A method of using a medical fluid injection system,the method comprising: executing a first interconnecting step comprisinginterconnecting a first patient-specific tubing set with a multi-patienttubing set, wherein said first patient-specific tubing set comprises afirst use indicator; executing a first directing step comprisingdirecting a medical fluid from said injection device through saidmulti-patient tubing set, and then through said first patient-specifictubing set; executing a first blocking step comprising blocking abackflow through said first patient-specific tubing set and into saidmulti-patient tubing step; and executing a first inducing stepcomprising inducing a single response by said first use indicator tosaid first directing step, wherein said single response is a physicalchange of said first use indicator.
 2. The method of claim 1, whereinsaid first inducing step comprises moving a first indicator element froma first position to a second position.
 3. The method of claim 2, furthercomprising retaining said first indicator element in said secondposition after said moving said first indicator element step.
 4. Themethod of claim 2, wherein said moving said first indicator element stepis initiated without deforming said first indicator element.
 5. Themethod of claim 2, wherein said moving said first indicator element stepcomprises moving said first indicator element into a visibly observableposition.
 6. The method of claim 2, wherein said moving said firstindicator element step comprises moving said first indicator elementinto an open space.
 7. The method of claim 1, further comprising:disconnecting said first patient-specific tubing set from saidmulti-patient tubing set; executing a second interconnecting stepcomprising interconnecting a second patient-specific tubing set withsaid multi-patient tubing set, wherein said second patient-specifictubing set comprises a second use indicator; executing a seconddirecting step comprising directing a medical fluid from said injectiondevice through said multi-patient tubing set, and then through saidsecond patient-specific tubing set; executing a second blocking stepcomprising blocking a backflow through said second patient-specifictubing set and into said multi-patient tubing step; and executing asecond inducing step comprising inducing a single response by saidsecond use indicator to said second directing step, wherein said singleresponse is a physical change of said second use indicator.
 8. Themethod of claim 7, wherein said second inducing step comprises moving asecond indicator element from a first position to a second position. 9.The method of claim 8, further comprising retaining said secondindicator element in said second position after said moving said secondindicator element step.
 10. The method of claim 8, wherein said movingsaid second indicator element step is initiated without deforming saidsecond indicator element.
 11. The method of claim 8, wherein said movingsaid second indicator element step comprises moving said secondindicator element into a visibly observable position.
 12. The method ofclaim 8, wherein said moving said second indicator element stepcomprises moving said second indicator element into an open space. 13.The method of claim 7, wherein said medical fluid for each of said firstand second directing steps is acquired from a common fluid source.